Replenine-VF, 50 IU/mL human factor IX, a powder for solution.
Land: Malta
Språk: engelska
Källa: Medicines Authority
Bipacksedel
(PIL)
31-05-2024
Produktens egenskaper
(SPC)
31-05-2024
Aktiva substanser:
FACTOR IX, HUMAN
Tillgänglig från:
Bio Products Laboratory Limited
ATC-kod:
B02BD04
INN (International namn):
FACTOR IX, HUMAN
Läkemedelsform:
POWDER FOR SOLUTION FOR INJECTION
Sammansättning:
FACTOR IX, HUMAN 50 international unit(s)/millilitre
Receptbelagda typ:
POM
Terapiområde:
ANTIHEMORRHAGICS
Bemyndigande status:
Authorised
Tillstånd datum:
2005-10-12
Bipacksedel
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REPLENINE
®
-VF 250 IU, 500 IU, 1000 IU
POWDER FOR SOLUTION FOR INJECTION
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Produktens egenskaper
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
REPLENINE
®
-VF
High Purity Factor IX
1.
NAME OF MEDICINAL PRODUCT
Replenine
®
-VF, 50 IU/mL human factor IX, a powder for solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Replenine-VF is a high purity factor IX. This product is prepared from plasma from
screened donors. Donors are selected from the USA.
Replenine-VF is presented as a sterile powder for solution, containing nominally 250 IU,
500 IU or 1000 IU human coagulation factor IX per vial. The product contains
approximately 50 IU/mL when reconstituted with either 5 mL (250 IU vial), 10 mL (500 IU
vial) or 20 mL (1000 IU vial) of Sterilised Water for Injections, Ph.Eur..
One mL of Replenine-VF contains approximately 100 IU of human coagulation factor IX
after reconstitution at half volume (see 6.6).
The potency (IU) is determined using the European Pharmacopoeia one stage clotting test.
The specific activity of Replenine-VF is approximately 100 IU per mg of protein.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Replenine-VF is a powder for solution; it is a freeze-dried concentrate of factor IX for
reconstitution with Sterilised Water for Injections, Ph.Eur.. After reconstitution with the
supplied sterile water diluent, the product is administered intravenously.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis in patients with haemophilia B (congenital factor IX deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physic
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